Ignite Creation Date:
2025-12-25 @ 4:07 AM
Ignite Modification Date:
2026-03-26 @ 10:19 PM
Study NCT ID:
NCT03093220
Status:
UNKNOWN
Last Update Posted:
2017-03-28
First Post:
2017-03-15
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Molecular Typing of Community-acquired Pneumonia Based on Multiple-omic Data Analysis
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D012141', 'term': 'Respiratory Tract Infections'}, {'id': 'D030342', 'term': 'Genetic Diseases, Inborn'}, {'id': 'D017714', 'term': 'Community-Acquired Infections'}], 'ancestors': [{'id': 'D007239', 'term': 'Infections'}, {'id': 'D012140', 'term': 'Respiratory Tract Diseases'}, {'id': 'D009358', 'term': 'Congenital, Hereditary, and Neonatal Diseases and Abnormalities'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': '1. Lower respiratory tract specimens including sputum, endotracheal aspiration and bronchoalveolar lavage fluid.\n2. Peripheral whole blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2018-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2017-03-15', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-03-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': '30 day mortality', 'timeFrame': '30 days after the onset of CAP', 'description': 'all-cause death in 30 days after the onset of CAP'}], 'secondaryOutcomes': [{'measure': 'complications', 'timeFrame': '30 days after the onset of CAP', 'description': 'nonfatal complications including critical organic or systematic dysfunction'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Respiratory Infections', 'Genetic Disorder', 'Community-Acquired Infections', 'Host-Pathogen Interactions']}, 'referencesModule': {'references': [{'pmid': '38259459', 'type': 'DERIVED', 'citation': 'Chen L, Xue J, Zhao L, He Y, Fu S, Ma X, Yu W, Tang Y, Wang Y, Gao Z. Lysophosphatidylcholine acyltransferase level predicts the severity and prognosis of patients with community-acquired pneumonia: a prospective multicenter study. Front Immunol. 2024 Jan 8;14:1295353. doi: 10.3389/fimmu.2023.1295353. eCollection 2023.'}, {'pmid': '37480410', 'type': 'DERIVED', 'citation': 'Yin L, Zhang Y, Zheng Y, Luo Q, Zhao L, Ni W, Xu Y, Gao Z. Early Detection of Aspergillus Species in Lower Respiratory Tract is Associated with Higher Mortality in Viral Community-Acquired Pneumonia: A Multicenter Prospective Cohort Study in China. Lung. 2023 Aug;201(4):387-396. doi: 10.1007/s00408-023-00638-2. Epub 2023 Jul 22.'}, {'pmid': '34692846', 'type': 'DERIVED', 'citation': 'Xie Y, Yu Y, Zhao L, Ning P, Luo Q, Zhang Y, Yin L, Zheng Y, Gao Z. Specific Cytokine Profiles Predict the Severity of Influenza A Pneumonia: A Prospectively Multicenter Pilot Study. Biomed Res Int. 2021 Oct 13;2021:9533044. doi: 10.1155/2021/9533044. eCollection 2021.'}, {'pmid': '33694084', 'type': 'DERIVED', 'citation': 'Chen L, Zhao L, Shang Y, Xu Y, Gao Z. Admission lysophosphatidylethanolamine acyltransferase level predicts the severity and prognosis of community-acquired pneumonia. Infection. 2021 Oct;49(5):877-888. doi: 10.1007/s15010-021-01585-x. Epub 2021 Mar 10.'}, {'pmid': '31046764', 'type': 'DERIVED', 'citation': 'Zheng Y, Ning P, Luo Q, He Y, Yu X, Liu X, Chen Y, Wang X, Kang Y, Gao Z. Inflammatory responses relate to distinct bronchoalveolar lavage lipidome in community-acquired pneumonia patients: a pilot study. Respir Res. 2019 May 2;20(1):82. doi: 10.1186/s12931-019-1028-8.'}, {'pmid': '30557448', 'type': 'DERIVED', 'citation': 'Luo Q, He X, Ning P, Zheng Y, Yang D, Xu Y, Shang Y, Gao Z. Admission Pentraxin-3 Level Predicts Severity of Community-Acquired Pneumonia Independently of Etiology. Proteomics Clin Appl. 2019 Jul;13(4):e1800117. doi: 10.1002/prca.201800117. Epub 2019 Feb 12.'}, {'pmid': '29759075', 'type': 'DERIVED', 'citation': 'Ning P, Zheng Y, Luo Q, Liu X, Kang Y, Zhang Y, Zhang R, Xu Y, Yang D, Xi W, Wang K, Chen Y, An S, Gao Z. Metabolic profiles in community-acquired pneumonia: developing assessment tools for disease severity. Crit Care. 2018 May 14;22(1):130. doi: 10.1186/s13054-018-2049-2.'}, {'pmid': '29368632', 'type': 'DERIVED', 'citation': 'Luo Q, Ning P, Zheng Y, Shang Y, Zhou B, Gao Z. Serum suPAR and syndecan-4 levels predict severity of community-acquired pneumonia: a prospective, multi-centre study. Crit Care. 2018 Jan 24;22(1):15. doi: 10.1186/s13054-018-1943-y.'}]}, 'descriptionModule': {'briefSummary': 'Community-acquired pneumonia (CAP) is a heterogeneous disease causing great morbidity, mortality and health care burden globally. Typing methods for discriminating different clinical conditions of the same disease are essential to a better management of CAP. Traditional typing systems based separately on clinical manifestations (such as PSI and CURB-65), pathogens(bacterial types, virulence, drug resistance, etc) or host immune state (immunocompetent, immunocompromised or immunodeficiency). Thus, they are barely able to represent the real disease status nor to precisely predict the mortality.\n\nAs the development of multi-omic technologies, the relatedness of different phenotypes at a molecular level have revolutionized our ability to differentiate among patients. Our study is aimed at establishing a novel molecular typing method of CAP. Multi-omic (including genomics, transcriptomes, and metabolisms) data obtained from enrolled CAP patients and isolated pathogens would be integrated analyzed and interpreted. Tthe investigators believe that an appropriate molecular typing method would lead to revolutionary changes in current arrangements of CAP.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'minimumAge': '16 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'all adult patients (aged \\> 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* adult (aged \\> 16 years)\n* diagnosed as community-acquired pneumonia\n\nExclusion Criteria:\n\n* being immunocompromised, including history of glucocorticoid taken for more than 1 month, history of immunosuppressive therapy, history of human immunodeficiency virus (HIV) infection, solid tumor or hematological malignancy\n* history of long-term nursing home stays\n* history of recently hospitalized (\\<90 days)'}, 'identificationModule': {'nctId': 'NCT03093220', 'briefTitle': 'Molecular Typing of Community-acquired Pneumonia Based on Multiple-omic Data Analysis', 'organization': {'class': 'OTHER', 'fullName': "Peking University People's Hospital"}, 'officialTitle': 'Molecular Typing of Adult Community-acquired Pneumonia in China', 'orgStudyIdInfo': {'id': '2016YFC0903800'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'community-acquired pneumonia', 'description': 'all adult patients (aged \\> 16 years) admit to the 4 hospitals between March 2017 and March 2018 with CAP will be enrolled'}]}, 'contactsLocationsModule': {'locations': [{'zip': '100044', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Yali Zheng, Dr', 'role': 'CONTACT', 'email': 'drylzheng@gmail.com', 'phone': '15011451515', 'phoneExt': '86'}], 'facility': "Peking University People's Hospital", 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Yali Zheng, Dr', 'role': 'CONTACT', 'email': 'drylzheng@gmail.com', 'phone': '15011451515', 'phoneExt': '86'}], 'overallOfficials': [{'name': 'Zhancheng Gao, Professor', 'role': 'STUDY_CHAIR', 'affiliation': 'Department of Respiratory Critical Care Medicine'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Peking University People's Hospital", 'class': 'OTHER'}, 'collaborators': [{'name': 'CapitalBio Group Corporation', 'class': 'UNKNOWN'}, {'name': 'Chinese Academy of Sciences', 'class': 'OTHER_GOV'}, {'name': 'West China Hospital', 'class': 'OTHER'}, {'name': 'Second Hospital of Jilin University', 'class': 'OTHER'}, {'name': 'Shanghai Pulmonary Hospital, Shanghai, China', 'class': 'OTHER'}], 'responsibleParty': {'type': 'SPONSOR'}}}}